|
| |
Fort Lewis College Institutional Review Board Exemption Criteria (from 45 CFR 46.101)
In order to qualify for exemption, all of the project activity must qualify as one or more categories from the left column. To qualify for a category, a project must meet the conditions to the right of the category.
Category Conditions
|
(1) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as: |
(a) Research on regular and special education instructional strategies,
OR
(b) Research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. |
|
(2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, if:
NOTE: all three conditions must apply. |
(a) Information obtained is recorded in such a manner that human subjects cannot be identified, directly or through identifiers linked to the subjects;
AND
(b) Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subject's financial standing, employability, or reputation;
AND
(c) Subjects are not under the age of 18 or members of a vulnerable class, including prisoners, pregnant women, individuals who are mentally disabled or economically or educationally disadvantaged. |
|
(3) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (2) above if: |
(a) The human subjects are elected or appointed public officials or candidates for public office;
OR
(b) Federal statutes(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter. |
|
(4) Research, involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if: |
(a) These sources are publicly available;
OR
(b) If the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. |
|
(5) Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: |
(a) Public benefit or service programs;
OR
(b) Procedures for obtaining benefits or services under those programs;
OR
(c) Possible changes in or alternatives to those programs or procedures;
OR
(d) Possible changes in methods or levels of payment for benefits or services under those programs. |
|
(6) Taste and food quality evaluation and consumer acceptance studies, if: |
(a) Wholesome foods without additives are consumed;
OR
(b) If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the USDA. |
|
|
|